Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07542730
Phase
PHASE4
Status
Recruiting
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Conditions

  • Abortion
  • Anxiety
  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diphenhydramine — DRUG
    Diphenhydramine 50 mg administered intravenously once prior to the procedure.
  • Placebo — DRUG
    Matching placebo composed of normal saline administered intravenously once prior to the procedure.

Study Details

This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.

Key Dates

First listed
Apr 21, 2026
Start date
Jun 29, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Diphenhydramine plus standard moderate sedation
    Participants receive intravenous diphenhydramine 50 mg prior to the procedure, in addition to standard moderate sedation with midazolam and fentanyl. Additional doses of midazolam and fentanyl may be administered during the procedure as clinically indicated.
  • Placebo Comparator: Placebo plus standard moderate sedation
    Participants receive a matching intravenous placebo (normal saline) prior to the procedure, in addition to standard moderate sedation with midazolam and fentanyl. Additional doses of midazolam and fentanyl may be administered during the procedure as clinically indicated.

Primary Outcome Measure

Participant-Reported Pain During Uterine Aspiration [ Time Frame: During the procedure, at the time of uterine aspiration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gender Wellness OB/GYNRochesterNew York14642-

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By research site
Gender Wellness OB/GYN· Rochester, NY

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